Image supplied by Citizen Systems Europe
|
Pharmaceutical labelling is more complex than ever, with increasing pressure from consumers and regulatory bodies to prevent
counterfeiting and improve safety. Manufacturers and packaging companies need to ensure products can be recognized and verified
quickly and easily throughout the supply chain, communicating vital information to retailers and distributors.
To achieve this, a more sophisticated labelling system than the European Article Number (EAN) barcode — the current retail
labelling standard — is needed in the pharmaceutical sector. Although conventional barcodes have revolutionized labelling
during the last 30 years, by today's standards they offer limited capacity for data handling in some applications; for example,
with thousands of individual product packs carrying the same barcode, it is impossible to check if a barcode has been copied
and used on counterfeit goods, or if products are destined for different markets. Furthermore, EAN barcodes provide no capacity
for batch or shipmentspecific data.
Tougher guidelines
The author says...
|
With ever more stringent guidelines being continuously introduced, these limitations need to be overcome. Most of the new
guidelines from regulatory bodies leave it to manufacturers to decide for themselves how they are going to meet the standards.
While this offers drug companies a degree of flexibility, it also presents them with the challenge of developing a system
that works for them and is compatible with the organizations they do business with worldwide. The time and resources needed
to address this problem also make it important that the chosen solution is flexible enough to justify a relatively high initial
investment.
A report by the FDA in 2004 included a number of widereaching guidelines for drugs manufacturers to help protect consumers
from counterfeit products.1 These recommendations included stricter licensing requirements, tougher penalties, increased education and collaboration
in the supply chain, and the use of new labelling technologies. While most manufacturers can see the benefits of implementing
more effective labelling systems, however, many are unsure of how to continue. With sometimes conflicting information offered
by the providers of competing systems, finding the right labelling solution can be difficult.
New labelling technologies
Today's drug manufacturers can choose from a wide selection of automatic identification and data capture (AIDC) technologies;
these have been developed to enable detailed productspecific data to be stored on labels, identified and communicated around
the world. Solutions range from printed barcodes to radio frequency identification (RFID) tags, but all essentially fulfil
the same purpose: a smarter, more versatile way of storing and sharing data.
For instance, using AIDC technologies, manufacturers can include product or batchspecific data in individual product labels.
In the pharma industry, this could enable suppliers and retailers to verify a product quickly and accurately — in most cases
using standard technology. Just as importantly, additional data can be encoded in the product labels as they pass through
the supply chain, providing detailed information on the journey a product has taken from manufacturer to consumer; therefore,
considerably improving traceability.
Perhaps the most publicized, and controversial, of these new labelling technologies is RFID. RFID tags can be read without
the need for close contact or a direct line of sight, and offer read/write functionality, which makes them ideal for tracking
products and monitoring processes. However, many decisionmakers remain confused about the capability of RFID, and the relatively
high cost and complexity of implementing the technology has prevented its progress in many areas, including the pharma industry.
The issue of compatibility has also been a stumbling block as manufacturers are hesitant to label products with tags that
other organizations throughout the supply chain may not have the technology or expertise to read or update.
2D barcodes
These issues have contributed to the growing popularity of the 2D barcode in pharmaceutical applications. The 2D barcode is
a development on the now ubiquitous EAN (1D) barcode, offering a more sophisticated level of data handling, while being considerably
cheaper and easier to implement than completely new technologies.
2D barcodes can hold considerably more information than standard barcodes (usually up to approximately 1000 characters of
information on a single label, depending on the level of encryption) making them better suited to meet the requirements of
today's manufacturers. This increased level of information can be held on a label the same size or smaller than a conventional
barcode label, and the codes can, in most cases, be printed using the same technology, helping to minimize the cost of upgrading.
Furthermore, as well as allowing product information to be accessible from a central database, 2D barcodes can also function
as a database themselves, providing a portable information source on the labelled product.
Currently, there are two types of 2D barcode available: stacked and matrix. Stacked barcodes are essentially multiple rows
of small standard barcodes stacked vertically above one another, which allows more information to be stored on a single label.
Matrix barcodes, specifically 'DataMatrix' codes, have so far been more popular in the pharmaceutical sector, partly because
of their ease of integration and compatibility. These matrix codes provide greater data capacity than the stacked type, and
can usually be scanned vertically or horizontally to make them easy to read.
While DataMatrix codes work in a similar way to conventional barcodes, they look quite different. The codes comprise a pattern
of black and white cells, typically in a square format. This makes them extremely spaceefficient and scaleable depending on
the amount of information to be stored.
Following years of development, DataMatrix codes are now a viable labelling solution for pharma manufacturers. This is partly
thanks to error detection and correction techniques that can be incorporated into the barcode to improve reliability and scan
success rates; for example, data can be duplicated several times to provide backups if part of the label is damaged.
